Director Technical Operations

JOB TITLE:Director, Technical Operations DEPARTMENT:Technical Operations REPORTING TO:SVP,Head of Technical Operations & Quality JOB PURPOSE Lead the pharmaceutical development activities to ensure the development of robust pharmaceutical products. Lead the pharmaceutical technology activities to provide technical support to existing commercial products. KEY DUTIES AND RESPONSIBILITIES Direct the development (analytical and formulation) and manufacture of pharmaceutical drug products, devices, and drug product-device combination products. Direct the development and validation of analytical methods for the testing of active ingredients, excipients, packaging materials, drug products, devices, and drug product-device combination products. Consistent with FDA standards, direct the process validation of to-be commercial drug products, devices, and drug product-device combination products. In addition, when changes have been made to the manufacture of commercial products, direct the re-validation of such products. Direct the technical transfer of commercial manufacturing and analytical testing of drug products, devices, and drug product-device combination products. Stay current with emerging technology and regulatory guidance within industry. Ensure effective partnership with other areas in the Company including Operations, Quality, Regulatory, Clinical and Pharmacovigilance. Support the preparation and maintenance of the Pharmaceutical Development & Pharmaceutical Technology budget. Represent Technical Operations in internal and external (vendor) meetings and teleconferences in a positive, collaborative manner. Responsible for ensuring that training and development programs for staff members are in place to meet future objectives of the business. Participates in Talent Management, succession planning, and talent acquisition. Demonstrate high levels of leadership and people management skills. Contribute to the review of company policies and procedures. Undertake any other duties, which may be assigned by Senior Management. HUMAN RESOURCE MANAGEMENT Adhere to the Companys policies and procedures. Provide guidance and support to your team. Manage performance expectations of your team in line with their descriptions and the company policies. This job description should not be regarded as conclusive or definite. It is a guideline within which the individual job holder works. It is not intended to be rigid or inflexible and may alter as the companys strategic direction changes. ESSENTIAL SKILLS Person Specification Education Degree in pharmacy, chemistry, or engineering Experience 5 yrs experience working within the pharmaceutical development and/or technical operations department of a pharmaceutical company. 2 yrs experience at a managerial level. Specialist knowledge Experience of developing new Drug Products. Knowledge of ICH regulations. Experience of developing drug/device combination products. Experience in the validation of drug product manufacturing processes. Special skills and dispositions Excellent interpersonal and leadership skills. Ability to be flexible and adaptable to change. Pro-active and self-motivated with a high level of initiative and persistence. Demonstratable ability to set and meet targets. Experience within a multidisciplinary team, interacting with Regulatory Authorities, drafting Regulatory eCTDS and INDs (module 3). Demonstratable ability to communicate fluently in English, both orally and in writing. Location Be available to attend place of work Larne, UK. Be amenable to work related travel, as required. DESIRABLE SKILLS PhD in Pharmacy, Chemistry, or engineering Experience in small to medium size pharmaceutical companies. Experience in the validation of drug product packaging processes. Experience in the development and validation of analytical methods. Millicent Pharma is not in a position to offer Visa sponsorship - therefore candidates will need to have the legal right to work in the UK Skills: Operations Director Director technical operations